SuicideNCT01287416
Circle of Life. Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide
A study testing Applied Suicide Intervention Skills Training and Resilience Retreat in people with Suicide, run by University of Manitoba at 1 site in Canada.
Trial summary
Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST) gatekeeper training will be significantly more likely to have increased knowledge and preparedness to help people with suicidal ideation than participants who receive the resilience retreat. Secondary Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- Applied Suicide Intervention Skills Training and Resilience Retreat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.
Who cannot join
- being less than 16 years of age
- prior training in SafeTALK or ASIST
- being an elected official in a First Nations community
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba Department of Psychiatry
Winnipeg, Manitoba, R3E 3N4
About this study
Official title: Circle of Life.Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide: A Randomized Controlled Pilot Study
Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST) gatekeeper training will be significantly more likely to have increased knowledge and preparedness to help people with suicidal ideation than participants who receive the resilience retreat.
Secondary Hypotheses:
- Participants in ASIST gatekeeper training will not have higher levels of post-intervention distress or suicidal ideation compared to the resilience retreat.
- High levels of distress, grief, and alcohol abuse will significantly impact on the learning and retention of suicide intervention skills.
Read the detailed description
Inclusion criterion: All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.
Exclusion criterion: Exclusion criteria for the study include being less than 16 years of age, prior training in SafeTALK or ASIST, being an elected official in a First Nations community, and inability to read or write.
Primary outcome: Skills in Suicide Intervention: Suicide Intervention Response Inventory.The Suicide Intervention Response Inventory (SIRI) will be used to detect enhancement of intervention skills in participants. The SIRI is a self-administered test that was designed to measure competence in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI has shown its good psychometric properties, freedom from social desirability effects, and responsiveness to training in suicide prevention. It contains 25 items, each of which consists of a "client" remark and two "helper" responses. Responses are judged based on response options made by highly expert suicidologists. The SIRI has shown good internal consistency with alpha of 0.834, and good test-retest reliability.
Secondary Outcomes:
- Knowledge about suicide, attitudes toward suicide, and self-reported preparedness to intervene with suicidal behavior will be measured by a series of questions that were developed by LivingWorks Inc.
- Gatekeeper behaviors will be measured similar to questions utilized by Wyman in the school-based study that assess how many people had the person asked others about suicide.
- Conditions
- Suicide
- Being tested
- Applied Suicide Intervention Skills Training, Resilience Retreat
- Keywords
- Suicide Intervention, Applied Suicide Intervention Skills Training (ASIST), Resilience Retreat, First Nations, Suicide Intervention and Response Inventory (SIRI)
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Suicide Intervention Skills TrainingBehavioural
Also called ASIST
Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop.
Resilience RetreatBehavioural
The Resilience Retreat is a 2-day, 14 hour session
| Study group | Role | What they receive |
|---|---|---|
| Applied Suicide Intervention Skills Training (ASIST) | Experimental | ASIST is a 2-day intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as "CPR" skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid. Receives: Behavioral: Applied Suicide Intervention Skills Training |
| Resilience Retreat | Active comparator | The two days will be divided into cultural activities, sharing circles, small group discussions, story telling and dance. Two First Nations community leaders will be identified to lead each of the two retreats. Receives: Behavioral: Resilience Retreat |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRI Questionnaire Score
The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.
Measured: pre-training, post-training and 6 mo follow up
Secondary outcomes (15)
Self-perceived Confidence in Helping a Suicidal Individual
Meaures the level of confidence that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all confident) to 4 (very confident).
Measured: pre-training, post-training and 6 month follow-up
Self-perceived Skill in Helping a Suicidal Individual
Measures the level of ability that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all skilled) to 4 (very skilled).
Measured: pre-training, post-training and 6 month follow-up
Self-perceived Knowledge About Suicide
Measures the level of knowledge about suicide that the individual believes they have based on a 4 point Likert scale ranging from 1 (not at all knowledgeable) to 4 (very knowledgeable).
Measured: pre-training, post-training and 6 month follow-up
Self-perceived Preparedness
Measures the level of preparedness of the individual to help someone who is suicidal based on a 4 point Likert scale ranging from 1 (not at all prepared) to 4 (very prepared).
Measured: pre-training, post-training and 6 month follow-up
Self-reported Distress
Measures the level of distress in the participant using the K6 distress scale. The scale is comprised of six questions which are scored from 0 (none of the time) to 4 (all of the time). The sum of the scores from all six questions was used to determine a total scale score which ranges from 0 (not at all distressed) to 24 (very distressed).
Measured: pre-training and 6 month follow-up
Self-reported Alcohol Use
Details participants' level of alcohol consumption and if it may be harmful according to the AUDIT. The AUDIT scale is comprised of ten questions with most questions being scored from 0 (never) to 4 (4 or more times per week). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (no risk related to alcohol) to 40 (high risk related to alcohol). Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.
Measured: pre-training and 6 month follow-up
Self-reported Resiliency Score
Assesses resiliency in the participant according to the Connor-Davidson Resilience Scale, 10-item. The CD-RISC 10 is comprised of ten questions scored from 0 (Not at all true) to 4 (True nearly all of the time). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (low resiliency) to 40 (highly resilient).
Measured: pre-training and 6 month follow-up
Lifetime Suicidal Ideation at Baseline
Number of people who endorsed having thought about suicide in their lifetime as measured at baseline
Measured: July 19-20, 2010
Lifetime Suicide Attempt at Baseline
Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline
Measured: July 19-20, 2010
Suicidal Ideation in Past 2 Days at Baseline
Number of people who endorsed having thought about suicide in the past 2 days as measured at baseline (not at all vs a little to a lot)
Measured: July 19-20, 2010
Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training
Number of people who endorsed having thought about suicide in the past 2 days as measured immediately post training (not at all vs a little to a lot)
Measured: July 22-23, 2010
Suicidal Ideation Since Training at 6 mo Follow-up
Number of people who endorsed having thought about suicide since the training as measured at 6 month follow-up (not at all vs a little to a lot)
Measured: January 28-31, 2011
Attempted Suicide Since Training at 6 mo Follow-up
Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up
Measured: January 28-31, 2011
Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts
Number of participants who have asked someone that they thought was at risk about suicidal thoughts since the training, measured at 6 month follow-up assessment.
Measured: January 28-31, 2011
Gatekeeper Behaviours - Did Not Ask Person at Risk
Number of participants who did not ask someone about their suicidal thoughts even though they thought they were at risk, measured at 6 month follow-up assessment based on time since training.
Measured: January 28-31, 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Jitinder Sareen, University of Manitoba
- Investigators
- Jitender Sareen, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287416
- Sponsor's protocol ID
- H2010:192
- Status last verified
- Apr 2014
- First submitted
- 10 Jan 2011
- Last updated
- 13 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sareen J, Isaak C, Bolton SL, Enns MW, Elias B, Deane F, Munro G, Stein MB, Chateau D, Gould M, Katz LY. Gatekeeper training for suicide prevention in First Nations community members: a randomized controlled trial. Depress Anxiety. 2013 Oct;30(10):1021-9. doi: 10.1002/da.22141. Epub 2013 Jun 12.
PubMed 23761133
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circle of Life.Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01287416
- Acronym / sponsor ID
- H2010:192
- Conditions
- Suicide
- Keywords
- Suicide Intervention, Applied Suicide Intervention Skills Training (ASIST), Resilience Retreat, First Nations, Suicide Intervention and Response Inventory (SIRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 13 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST) gatekeeper training will be significantly more likely to have increased knowledge and preparedness to help people with suicidal ideation than participants who receive the resilience retreat.
Secondary Hypotheses:
- Participants in ASIST gatekeeper training will not have higher levels of post-intervention distress or suicidal ideation compared to the resilience retreat.
- High levels of distress, grief, and alcohol abuse will significantly impact on the learning and retention of suicide intervention skills.
Detailed description
Inclusion criterion: All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.
Exclusion criterion: Exclusion criteria for the study include being less than 16 years of age, prior training in SafeTALK or ASIST, being an elected official in a First Nations community, and inability to read or write.
Primary outcome: Skills in Suicide Intervention: Suicide Intervention Response Inventory.The Suicide Intervention Response Inventory (SIRI) will be used to detect enhancement of intervention skills in participants. The SIRI is a self-administered test that was designed to measure competence in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI has shown its good psychometric properties, freedom from social desirability effects, and responsiveness to training in suicide prevention. It contains 25 items, each of which consists of a "client" remark and two "helper" responses. Responses are judged based on response options made by highly expert suicidologists. The SIRI has shown good internal consistency with alpha of 0.834, and good test-retest reliability.
Secondary Outcomes:
- Knowledge about suicide, attitudes toward suicide, and self-reported preparedness to intervene with suicidal behavior will be measured by a series of questions that were developed by LivingWorks Inc.
- Gatekeeper behaviors will be measured similar to questions utilized by Wyman in the school-based study that assess how many people had the person asked others about suicide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applied Suicide Intervention Skills Training (ASIST) | Experimental | Behavioral: Applied Suicide Intervention Skills TrainingASIST is a 2-day intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as "CPR" skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid. |
| Resilience Retreat | Active comparator | Behavioral: Resilience RetreatThe two days will be divided into cultural activities, sharing circles, small group discussions, story telling and dance. Two First Nations community leaders will be identified to lead each of the two retreats. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.
Key exclusion criteria (3 listed)
- being less than 16 years of age
- prior training in SafeTALK or ASIST
- being an elected official in a First Nations community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied Suicide Intervention Skills TrainingAlso: ASISTApplied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. | Behavioural | Applied Suicide Intervention Skills Training (ASIST) |
| Resilience RetreatThe Resilience Retreat is a 2-day, 14 hour session | Behavioural | Resilience Retreat |
Primary outcome
SIRI Questionnaire Score
Time frame: pre-training, post-training and 6 mo follow up
The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.
15 secondary outcomes
Self-perceived Confidence in Helping a Suicidal Individual
Time frame: pre-training, post-training and 6 month follow-up
Self-perceived Skill in Helping a Suicidal Individual
Time frame: pre-training, post-training and 6 month follow-up
Self-perceived Knowledge About Suicide
Time frame: pre-training, post-training and 6 month follow-up
Self-perceived Preparedness
Time frame: pre-training, post-training and 6 month follow-up
Self-reported Distress
Time frame: pre-training and 6 month follow-up
Self-reported Alcohol Use
Time frame: pre-training and 6 month follow-up
Self-reported Resiliency Score
Time frame: pre-training and 6 month follow-up
Lifetime Suicidal Ideation at Baseline
Time frame: July 19-20, 2010
Lifetime Suicide Attempt at Baseline
Time frame: July 19-20, 2010
Suicidal Ideation in Past 2 Days at Baseline
Time frame: July 19-20, 2010
Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training
Time frame: July 22-23, 2010
Suicidal Ideation Since Training at 6 mo Follow-up
Time frame: January 28-31, 2011
Attempted Suicide Since Training at 6 mo Follow-up
Time frame: January 28-31, 2011
Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts
Time frame: January 28-31, 2011
Gatekeeper Behaviours - Did Not Ask Person at Risk
Time frame: January 28-31, 2011
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23761133Sareen J, Isaak C, Bolton SL, Enns MW, Elias B, Deane F, Munro G, Stein MB, Chateau D, Gould M, Katz LY. Gatekeeper training for suicide prevention in First Nations community members: a randomized controlled trial. Depress Anxiety. 2013 Oct;30(10):1021-9. doi: 10.1002/da.22141. Epub 2013 Jun 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jitender Sareen, MD principal investigator
Department of Psychiatry, Faculty of Medicine, University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Suicide Intervention Skills Training and Resilience Retreat in people with Suicide, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRI Questionnaire Score (time frame: pre-training, post-training and 6 mo follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.